Description This role ensures GMP and GxP compliance in dispensing manufacturing and packaging Responsibilities include machine and area clearance product sampling in-process checks batch record reviews and raw material verification The position also involves approving packaging details reviewing environmental and calibration records managing change controls and deviations and ensuring proper labelling and document archiving Essential Functions To perform Machine and area clearance during dispensing manufacturing and packaging operation To perform sampling of blend finished product reserve sample stability sample hold time samples and other in process samples and tmanage sampling aids To carry out in process checks AQL and ANSI Sampling as per respective documents viz protocol BMR BPR SOPs and other GxP documents Review of Master BMR SOPs Batch Record Review and Batch Release Shop floor management To ensure GMP practices at manufacturing shop floor To verify raw material dispensing activity To approve batch coding details during packaging operation Review of executed batch records and release for next processing stage Preparation and review of CPV data trend To perform impact assessment of breakdown memo To initiate change control unplanned and planned deviation wherever required To review area equipment and cleaning log and tensure proper labelling To review environmental monitoring record calibration records and executed Batch Manufacturing and packaging Records and respective electronic records To perform calibration of IPQA instruments To ensure appropriate labelling during manufacturing and packaging Storage handling and dispensing of printed packing materials To review and approve packaging artworks proofs and shade cards To archive executed documents like BMR BPR Hold time Protocol etc To review and approve the Quality Notification Viz Change control and Deviation during Batch Manufacturing packaging Additional Responsibilities To monitor and record the environmental condition of label control room To prepare and revise functional SOPs wherever required Activities other than defined in the Job Responsibility are to be done as per the requirement of HOD by following HODS instructions and guidance Skills In-Process Checks Monitoring - Advanced Batch Record Review - Advanced Compliance and Regulatory Knowledge - Advanced Internal Audits and Inspections - Advanced Document and Record Review - Advanced Line Clearance Batch Record Review - Advanced Process Deviation Identification Handling - Advanced Audit Regulatory Inspection Readiness USFDA EMA MHRA EUGMP WHO - Intermediate Risk Assessment Change Control - Mastery Monitors production processes in real-time to ensure compliance with specifications and GMP - Intermediate Education B Pharm M Sc M Pharm Experience 7 years or more in 7- 9 years Expert in IPQA related all the key functions